Micronized dHACM Injectable for the Treatment of Plantar Fasciitis

Fasciitis, Plantar Clinical Trial

Official title:

A Phase 3, Prospective, Double-Blinded, Randomized Controlled Trial of the Micronized dHACM Injection As Compared To Saline Placebo Injection In The Treatment Of Plantar Fasciitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03414268
• Other study ID #: AIPF007
• Status: Completed
• Phase: Phase 3
• Start date: January 8, 2018
• Est. completion date: March 17, 2021

Study information

• Verified date: October 2020
• Source: MiMedx Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, double-blinded, randomized controlled trial of the micronized dHACM injection as compared to the saline placebo injection in the treatment of plantar fasciitis

Description:

Approximately 276 patients will be enrolled in this study. Each patient will receive 1 injection and be evaluated for efficacy and safety during a 6-month observation period. Randomization will be 1:1. The study is expected to be completed within 34 months, inclusive of enrollment and follow-up of all subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: March 17, 2021
• Est. primary completion date: March 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 79 Years

Eligibility

Inclusion Criteria:

1. Confirmed diagnosis of plantar fasciitis for = 1 month (30 days) and = 18 months by the investigator

2. VAS Pain scale of = 45 mm at randomization

3. Plantar fasciitis with conservative treatment for = 1 month (30 days), including any

of the following modalities:

• RICE
• Stretching exercises
• NSAIDs
• Orthotics

4. Diagnostic X-Ray within 6 months of enrollment showing view of calcaneus negative for calcaneal fracture or structural abnormalities

5. BMI = 40 kg/m2

6. Age = 21 years and < 80 years

7. Ability to sign Informed Consent and Release of Medical Information Forms

8. Ability to receive and respond to text messages or emails on a daily basis.

Exclusion Criteria:

1. Prior surgery or trauma to the affected site

2. Subjects requiring bilateral plantar fasciitis treatment at time of enrollment

3. Prior use of any lower limb injection therapy, including corticosteroids or PRP in either limb within the last 3 months

4. Has diabetes either Type I or Type II.

5. Systemic disorders associated with enthesopathy (disorder of entheses, i.e. bone attachments) such as Gout, Reiter's syndrome, rheumatoid arthritis, etc.

6. The presence of diagnosed comorbidities that can be confused with or can exacerbate

the condition- to be assessed by X-ray - including but not limited to:

• Calcaneal stress fracture
• Nerve entrapment syndrome (diagnosed as Baxter Nerve Syndrome)
• Fat pad atrophy
• Acute traumatic rupture of the plantar fascia
• Calcaneal tumor
• Tarsal tunnel syndrome (diagnosed)
• Significant bone deformity of the foot that may interfere with the study

7. Affected site exhibits clinical signs and symptoms of infection

8. Known allergy or known sensitivity to Aminoglycosides

9. Subjects who are non-ambulatory

10. History of more than 14 days treatment with immuno-suppressants (including systemic corticosteroids) or cytotoxic chemotherapy within 30 days prior to enrollment, or who are anticipated to require such medications during the course of the study

11. Prior radiation at the site

12. Use of any investigational drug(s) or therapeutic device(s) within 3 months preceding enrollment

13. Immune disorders including Systemic Lupus Erythematosus (SLE), Fibromyalgia, Acquired Immunodeficiency Syndrome (AIDS) or Human Immunodeficiency Virus (HIV)

14. History of any condition (including drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of or compliance with the study protocol, in the judgment of the investigator

15. Pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study OR are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence)

16. Workers' compensation subjects

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar

Intervention

Other:
• Micronized dHACM
1 mL injection of 40 mg Micronized dehydrated human amnion/chorion membrane (dHACM)

Drug:
• Saline Injection
Injection of 1mL 0.9% Sodium Chloride Injection, USP

Locations

Country	Name	City	State
United States	University Orthopedics Center	Altoona	Pennsylvania
United States	Union Podiatry	Baltimore	Maryland
United States	Bay Pines VA Healthcare System	Bay Pines	Florida
United States	ILD Research Center	Carlsbad	California
United States	Center for Clinical Research	Carmichael	California
United States	Limb Preservation Platform, Inc.	Fresno	California
United States	Horizon Clinical Research	La Mesa	California
United States	Advanced Foot & Ankle Center	Las Vegas	Nevada
United States	Foot and Ankle Clinic	Los Angeles	California
United States	Futuro Clinical Trials, LLC	McAllen	Texas
United States	Five Cities Foot Clinic	Pismo Beach	California
United States	Endeavor Clinical Trials	San Antonio	Texas
United States	Gulfcoast Research Institute, LLC	Sarasota	Florida
United States	Doctors Research Network	South Miami	Florida
United States	University Orthopedics Center	State College	Pennsylvania
United States	Southern Arizona VA Health Care System	Tucson	Arizona
United States	Coastal Podiatry	Virginia Beach	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
MiMedx Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in VAS score	Visual Analog Scale for Pain:	90 Days
Primary	Incidence of adverse events	The incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events during the first 12 months post injection	180 Days
Secondary	Foot Function Index - Revised (FFI-R) (Short Form)	Foot Function Index - Revised: Patient Reported Questionnaire	90 Days